Medical Device Registration and Approval in Honduras
General country-specific regulatory information is provided on this page for medical device registration and approval in Honduras. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Honduras, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Honduras
REGULATORY AUTHORITY: Medical devices are regulated by the DGRS (Dirección General de Registros Sanitarios).
CLASSIFICATION SYSTEM: Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.
TIMEFRAME: The licensing process takes approximately six months.
LICENSE VALIDITY: Licenses issued in Honduras expire after five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
ADDITIONAL INFORMATION: The licensing process is expedited for devices which have already been approved in Canada or Japan.
Last updated on January 29 2015.
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